Clinical Development Manager - Lifelancer
San Francisco, CA
About the Job
Job Title: Clinical Development Manager
Job Location: San Francisco, CA, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
About Loyal
Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.
Weve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track to bring the first product to market in 2025.
Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.
About The Role
Were seeking an experienced Clinical Development Manager that is responsible for clinical development of Loyals programs and be the primary owner of the following activities: development and finalization of clinical protocol, Investigators Brochure, Informed Consent Forms (ICF) and study report, medical monitoring, and training on protocol compliance. Additional responsibilities include assisting with regulatory submissions and providing clinical perspectives (ie, acting as an internal consultant) to colleagues in clinical operations, commercial, data science, manufacturing, preclinical pharmacology and pharmacokinetics. .
You will be reporting to our VP, Clinical and Veterinary Medicine - Ellen Ratcliff.
Your daily work will include:
Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.
Our values
Lean into moonshots
We dont settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.
Opportunity is at the intersection
We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
Expertise without ego
Titles do not determine who has a voice. We work on hard, technical problems and have a ton of fun while at it.
Learning by doing
Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
Lead with context
We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.
Empathy and respect for all life
Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.
Weve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track to bring the first product to market in 2025.
Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.
About The Role
Were seeking an experienced Clinical Development Manager that is responsible for clinical development of Loyals programs and be the primary owner of the following activities: development and finalization of clinical protocol, Investigators Brochure, Informed Consent Forms (ICF) and study report, medical monitoring, and training on protocol compliance. Additional responsibilities include assisting with regulatory submissions and providing clinical perspectives (ie, acting as an internal consultant) to colleagues in clinical operations, commercial, data science, manufacturing, preclinical pharmacology and pharmacokinetics. .
You will be reporting to our VP, Clinical and Veterinary Medicine - Ellen Ratcliff.
Your daily work will include:
- Medical monitoring of ongoing clinical trials, requiring (1) solid understanding of the pharmacology/toxicology profile of drug compounds and (2) strong clinical competency in assessing medical observations/lab findings.
- Planning and authoring regulatory submissions for clinical trials, final study reports (including statistical analysis discussion and interpretation).
- Analyzing R D data and leveraging results to design and execute optimal clinical studies.
- Contributing to the design of development pathways, starting from preclinical studies through full FDA CVM approval.
- Frequent interactions with pre-clinical teams, data scientists, drug development, regulatory and strategy and clinical operations teams.
- DVM or equivalent degree from an AVMA-accredited school.
- 5+ years of clinical practice experience.
- Prior industry experience as medical monitor/study director is nice-to-have, but not required.
- Familiarity with good clinical practice (GCP) guidelines and regulations.
- Enjoy serving as the veterinary medical expert to bridge gaps between diverse subteams/functions, ranging from RD, clinical operations, manufacturing and commercial/go-to-market activities.
- Tech-savvy, or can be trained quickly to use new software, platforms or applications.
- Think creatively, anticipate challenges, and develop innovative solutions to complex problems.
- A commitment to scientific excellence, integrity, and ethical conduct in all aspects of drug development.
- Full-coverage health insurance — medical, dental and vision — for you and your dependents
- $1,000 home office equipment stipend
- $1,200/year learning budget for books, courses, etc.
- $250/month wellness budget for gym, cleaners, spa, food, etc.
- All 3-day weekends are turned into 4-day weekends
- Unlimited vacation and paid holidays
- Paw-ternity leave — adopt a dog and get a day off with your new family member
- Annual company retreat at beautiful locations across the country (recently: Tahoe, Cape Cod)
- Competitive salary
- Company equity options grant for new hires
Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.
Our values
Lean into moonshots
We dont settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.
Opportunity is at the intersection
We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
Expertise without ego
Titles do not determine who has a voice. We work on hard, technical problems and have a ton of fun while at it.
Learning by doing
Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
Lead with context
We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.
Empathy and respect for all life
Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
https://lifelancer.com/jobs/view/9cae16c0b13f7132e5ca9dd4c4c8ab33
Source : Lifelancer